HAND SANITIZER WOLKE- alcohol gel

HAND SANITIZER WOLKE by

Drug Labeling and Warnings

HAND SANITIZER WOLKE by is a Otc medication manufactured, distributed, or labeled by Hidro Soluciones Integrales, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin when water, soap & towel are not available - Recommended for repeated use.

Warnings

- For external use only.

Flammable - Keep away from fire or flame.

When using this product

keep out of eyes, In case of contact with eyes, rinse thoroughly with water. Do not use on broken or irritated skin.

Stop use and ask a doctor if

irritation or redness develop and last more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other information

• Do not store above 105 °F (40 °C).
• May discolor certain wood surfaces.

Inactive Ingredients:

Purified water, carbomer, triethanolamine, glycerin.

Package Labeling:

INGREDIENTS AND APPEARANCE

HAND SANITIZER WOLKE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78207-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78207-001-01	3700 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2020

Labeler - Hidro Soluciones Integrales, S.A. de C.V. (951577999)